FDA’s New Guidance on Mandatory Cosmetic Recalls

When the Modernization of Cosmetics Regulation Act (MoCRA) was signed into law in December 2022, FDA’s authority to regulate cosmetic products was significantly expanded. Prior to the passage of MoCRA, FDA had limited authority regarding cosmetic product registration, testing, good manufacturing practices, mandatory risk labeling, adverse event reports and recalls.

Based on MoCRA’s main objective of improving the safety of cosmetics sold in the United States, FDA made it mandatory for all U.S. and foreign cosmetic manufacturers to register and list their products with FDA. Prior to this, FDA registration was voluntary. As of January 6, 2026, FDA had recorded:

In addition, cosmetic companies have been mandated to report serious adverse events and maintain safety substantiation evidence to ensure their products are safe before marketing. FDA will also promulgate final GMP regulations that cosmetic manufacturers must follow.

From voluntary to mandatory recalls

Prior to MoCRA, cosmetic product recalls were voluntary. In other words, FDA could encourage companies to voluntarily recall violative cosmetics from the marketplace, but it could not legally require a recall.

Under MoCRA, FDA was given mandatory recall authority. MoCRA added section 611 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act). If the Agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded, and that the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person at the cosmetic company refuses to do so voluntarily.

What the final guidance covers

To clarify its mandatory recall authority, FDA issued a draft guidance in December 2025 titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” On October 22, 2026, the Agency finalized this guidance with no substantive changes from the draft.

The guidance is in the form of questions and answers. It provides answers to common questions that might arise about the mandatory recall provisions and FDA’s current thinking regarding their implementation, and it discusses the circumstances under which FDA may use its mandatory recall authority and the factors and evidence it will consider in its decision-making.

FDA also clarified the procedural steps, starting with an opportunity for responsible parties to voluntarily cease distribution and conduct a product recall, and escalating to a formal FDA recall order should the voluntary actions be found insufficient.

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